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Rexulti

Generic name: brexpiprazole [brex-PIP-ra-zole]
Drug class: atypical antipsychotics

What is Rexulti?

Rexulti, a prescription antipsychotic, is used to treat major depressive disorder (MDD), schizophrenia, and agitation due to dementia caused by Alzheimer's.Rexulti is not known to work in a specific way but is believed to alter the action of chemicals such as serotonin or dopamine.

Warnings

Rexulti has not been approved for older adults who have dementia-related psychosis.Be cautious of young adults taking this medication who express suicidal tendencies upon first use; pay close attention to any changes in mood or symptoms that emerge as you monitor for effects on mood or symptoms.Be alert to any changes in mood or symptoms. Notify your doctor of any new symptoms or worsening symptoms.Rexulti may be safe and effective for children with major depression disorders. It is unknown if Rexulti is effective and safe for children with schizophrenia under the age of 13.

Before you take this drug

Rexulti is not approved to be used in this way. It may increase the death risk for older adults who have dementia-related psychosis.Rexulti should not be used if you have an allergy to brexpiprazole.

Inform your doctor immediately of any of the following:

  • Diabetes, or high blood glucose;
  • Liver disease
  • Kidney disease
  • High cholesterol (or triglycerides, a type of fat found in the blood);
  • High or low blood pressure?
  • Stroke or heart attack
  • A seizure;
  • Low white blood cell counts (WBC).

When first starting an antidepressant, some young people may have suicidal thoughts. Regular visits to your doctor are a good way for you and your doctor to monitor the progress of your treatment.Your family or caregivers should remain alert for any shift in mood or symptoms that might indicate depression or substance use disorder.Antipsychotic medication taken in the last three months of pregnancy can cause respiratory problems, feeding difficulties, or withdrawal symptoms for the newborn. If you get pregnant, tell your doctor right away. Do not stop taking Rexulti before consulting your doctor.You may find your name on a registry for pregnant women to monitor the effects of brexpiprazole.Breastfeeding may not be possible while taking this medication. You should consult your doctor if you are concerned about any risks.

How to take Rexulti?

Rexulti should be taken exactly as prescribed by your physician. Read all the instructions and directions that come with your prescription. Sometimes, your doctor will change the dose. You must take the medication exactly as prescribed.Rexulti may be taken either with or without food.You should drink plenty of fluids in hot weather or when exercising. Rexulti can cause dehydration.Do not suddenly stop taking this medication. Your condition could worsen if you stop abruptly.Rexulti can cause hyperglycemia (high blood sugar). Check your blood sugar regularly if you have diabetes.Store away from heat and moisture at room temperature.

Rexulti can be used in conjunction with antidepressants to treat major depression disorders among adults.Rexulti can be used to treat schizophrenia among adults and children over the age of 13.Rexulti can also be used to treat agitation caused by Alzheimer’s disease.

Details on dosage

Adult dose for major depressive disorder:

Initial dose: orally, 0.5 to 1 mg once daily.
Titration regimen: Depending on the clinical response and tolerance, dosage increases should be made at weekly intervals. Start with 1 mg per day, then increase to 2 mg.
Maintenance dose: oral, 2 mg once daily
Maximum dose: 3 mg/day

Comment: Healthcare providers need to periodically assess the need for maintenance treatments.

Adjunctive treatment for major depressive disorder

Adult dose for schizophrenia:

Initial dose: Orally, 1 mg once daily on Days 1 to 4.
Titration regimen: Depending on the clinical response and tolerance, titrate up to 2 mg twice a day on Days 5 through 7, then 4 mg once every day on Day 8.
Maintenance dose: oral, 2 to 4 mg once daily
Maximum dose: 4 mg/day

Treatment of schizophrenia

Adult dose for Agitation Due to Alzheimer's Disease:

Initial dose: orally, 0.5 mg once daily on Days 1–7.
Titration regimen: Based upon clinical response and tolerance, titrate up to 1 mg twice a day on Days 8–14. Then to 2 mg twice a day on Day 15.
Maintenance dose: oral, 2 mg once daily
Maximum dose: 3 mg/day, based on clinical response after 14 days.

Use: Treatment for agitation due to Alzheimer's.

Usual pediatric dose for schizophrenia:

Initial dose: Orally, 0.5 mg once daily on days 1 to 4.
Titration regimen: Based upon clinical response and tolerance, titrate up to 1 mg twice a day on Days 5 through 7, then 2 mg on Day 8.
Maintenance dose: orally, 2 mg to 4 mg once daily. Weekly doses can be increased in increments of 1 mg.
Maximum dose: 4 mg/day
Use: Treatment for schizophrenia in children aged 13–17

What happens if I miss the dose?

If you are almost due for your next dose, skip the missed one. Never take two doses of the same medicine at once.

What happens if I overdose?

Call 1-800-222-1222 for poison help or seek immediate medical attention.

What should be avoided?

Do not drive or engage in hazardous activities until you have determined how the medicine will affect you. You may be unable to react properly.You may get dizzy if you stand up quickly from a seated or lying position.Avoid overheating or dehydration in hot weather. Brexpiprazole may make it difficult for your body's temperature to be controlled. This medicine can make it easier for you to become dangerously dehydrated and overheated.

Side effects of Rexulti

If you experience any of the following symptoms of an allergic reaction: itching; difficulty breathing; swelling in your face, lips, or throat;You should tell your doctor if any symptoms worsen or change, including changes in mood or behavior, anxiety, panic attacks, or trouble sleeping. Also, you may feel more impulsive, irritable, agitated, hostile, or aggressive.Rexulti in high doses or for a long time can cause serious movement disorders that are not always reversible. This disorder is more likely to occur if you take this medication for a long time, particularly if you have diabetes or are an older adult.

If you experience:

  • Uncontrolled facial movements (such as lip smacking and frowning; tongue movement or blinking);
  • Trouble swallowing
  • Heat intolerance, feeling of warmth
  • A seizure (convulsions);
  • Feeling light-headedness as though they could pass out.
  • High blood sugar: increased thirst, increased urination, and dry mouth
  • Low counts of white blood cells; fever; mouth sores and skin sores; sore throat; coughing; difficulty breathing
  • Severe reaction of the nervous system: stiff muscles, fever, sweating, and confusion; fast or irregular heartbeats or tremors.
  • Signs of a Blood Clot: sudden numbness, weakness, difficulty with speech or vision, swelling, or redness on an arm or leg.

While taking this medication, you may experience increased sexual desire, urges to gamble, or other intense desires. Whenever this occurs, contact your physician immediately.

Rexulti may cause side effects such as:

  • Weight gain or weight gain.
  • Feeling restless or unable to stay still.

There may be other side effects. For medical advice on side effects, call your doctor. Contacting the FDA directly can be done at 1-800-FDA-1088 if any adverse events arise from medical products.

Interaction with other drug

Sometimes combining medications may not be safe. Certain medicines could alter blood levels of other medications you are taking and cause side effects or reduce effectiveness, potentially increasing risks or making treatments less efficient.Brexpiprazole may interact with various drugs, including prescription and over-the-counter medicines, vitamins, and herbal products. Be sure to inform your physician of all medicines you are currently using as well as those you stop or start using - including any that become unavailable due to switching providers or discontinuance.

DRUG STATUS

Availability

Prescription only

Pregnancy & Lactation

CSA Schedule*
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